Formation et qualification:
- BSc in Biology, Biochemistry, Chemical Engineering, Bioengineering or relevant discipline with minimum 7 years of relevant industrial experience or MSc / PhD with minimum 2 years of relevant industrial experience
- Exposure to ISO 13485 quality management system and cGMPs is an asset
- Hands-on experience running lab and pilot scale experiments and equipment is required
- Experience of cell culture and bioreactor operation is required
- Experience of suspension and adherent cell line scale up is an asset
- Experience with microcarriers is an asset
- General knowledge of cell culture media design and troubleshooting is an asset
- Experience in the downstream purification of proteins is an asset
- Experience with characterization and assay development of proteins is an asset
- Good understanding of the challenges associated with scale-up and technology transfer is an asset
- Must have a strong focus on continuous improvement
- Must be able to multitask
- Effective oral and written communication skills, as well as strong interpersonal skills, are required
- Capable of working effectively in multidisciplinary teams and delivering complex objectives under aggressive timelines
- Management/supervisory experience is an asset
Tâches et responsabilités:
- Responsible for the design, optimization and implementation of upstream process development and scale-up manufacture for the production of proteins, to include the evaluation of microcarrier technology as a scale-up platform
- Lead Upstream Process Development aspects associated with technology transfer from Research and Development to Manufacturing
- May be required to assist in the development and scale-up of new and existing protein purification processes
- Review and optimize processes and process controls for existing products to improve process yields and reduce costs while maintaining product quality.
- Collaborate with other Process Development teams, RnD, Manufacturing, Analytical and Quality to enhance cross-functional transparency and executional success.
- Collaborate with RnD and Quality to define critical quality attributes and critical process parameters to set meaningful product specifications, through development batch production, method development and testing.
- Work with the Manufacturing team to implement new processes, including documentation and technical know-how.
- Work closely with the Process Engineering team to implement best practices for unit operations of the manufacturing process e.g. filtration techniques
- Lead root cause investigations and assist in the execution of corrective and preventative actions for process-related non-conformances.
- Train and mentor junior staff.
- Provide technical input and directions during capital projects from concept through detailed design.
- Prepare and review documentation for projects, development and validation studies, and Tech Transfer.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities. If you are interested in this challenging and rewarding position, please apply online at https://jobs.stemcell.com/